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经导管主动脉瓣植入术治疗重度主动脉瓣反流:J-Valve 系统的中期随访研究。

Transcatheter aortic valve implantation for severe aortic regurgitation using the J-Valve system: A midterm follow-up study.

机构信息

Department of Cardiac Surgery, Nanjing Drum Tower Hospital Clinical College of Nanjing Medical University, Nanjing, China.

Department of Cardiac Surgery, Nanjing Drum Tower Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences, Graduate School of Peking Union Medical College, Nanjing, China.

出版信息

Catheter Cardiovasc Interv. 2024 Nov;104(5):1052-1059. doi: 10.1002/ccd.31196. Epub 2024 Sep 9.

Abstract

BACKGROUND

Transcatheter aortic valve implantation (TAVI) is a well-established intervention for severe aortic valve stenosis. However, its application for severe aortic regurgitation (AR) is still under evaluation. This study aims to present the 3-year follow-up outcomes of the J-Valve system in managing severe AR.

AIMS

The aim of this study was to evaluate the mid-term efficacy and durability of the J-Valve system in the treatment of severe AR and to provide new information on this intervention.

METHODS

In this retrospective, single-center study, we evaluated the prognostic outcomes of patients with AR, who underwent treatment with the J-Valve system at Nanjing Drum Tower Hospital. Consecutive patients who were treated with the J-Valve were included in the analysis. The study focused on the echocardiographic follow-up to assess the effectiveness and durability of the J-Valve system in managing AR.

RESULTS

From January 2018 to December 2022, 36 high-risk AR patients treated with the J-Valve system had a procedural success rate of 97.2%, with one case requiring open-heart surgery due to valve displacement. Significant improvements were observed in left ventricular diameter (from 63.50 [58.75-69.50] mm to 56.50 [53.00-60.50] mm, p < 0.001) and left atrial diameter (from 44.00 [40.00-45.25] mm to 39.00 [36.75-41.00] mm, p = 0.003) postsurgery. All patients completed the 1-year follow-up, with an overall mortality rate of 2 out of 36 (5.6%). Among the surviving patients, there was one case of III° atrioventricular block and one case of stroke, both occurring within 90 days postsurgery. After a 3-year follow-up, 15.0% of patients had mild or moderate valvular regurgitation, with no cases of moderate or severe paravalvular leak. Additionally, 89.5% of patients were classified as New York Heart Association class I or II, showing significantly enhanced cardiac function.

CONCLUSION

The J-Valve system has shown positive therapeutic outcomes in treating AR, with notable effectiveness in managing the condition and significant improvements in heart failure symptoms and cardiac remodeling. However, due to the limited sample size and partial follow-up data, it is important to emphasize the need for further research with comprehensive long-term follow-up, to fully validate these results.

摘要

背景

经导管主动脉瓣置换术(TAVI)是一种成熟的治疗严重主动脉瓣狭窄的介入手段。然而,其在严重主动脉瓣反流(AR)中的应用仍在评估中。本研究旨在介绍 J-Valve 系统治疗严重 AR 的 3 年随访结果。

目的

本研究旨在评估 J-Valve 系统治疗严重 AR 的中期疗效和耐久性,并为该介入治疗提供新的信息。

方法

本回顾性单中心研究纳入了在南京鼓楼医院接受 J-Valve 治疗的 AR 患者的预后结局。连续接受 J-Valve 治疗的患者纳入分析。研究重点是超声心动图随访,以评估 J-Valve 系统治疗 AR 的有效性和耐久性。

结果

自 2018 年 1 月至 2022 年 12 月,36 例高危 AR 患者接受 J-Valve 系统治疗,手术成功率为 97.2%,1 例因瓣膜移位需行开胸手术。术后左心室直径(从 63.50[58.75-69.50]mm 降至 56.50[53.00-60.50]mm,p<0.001)和左心房直径(从 44.00[40.00-45.25]mm 降至 39.00[36.75-41.00]mm,p=0.003)均显著改善。所有患者均完成 1 年随访,36 例患者中有 2 例(5.6%)死亡。在存活患者中,1 例术后 90 天内发生 III°房室传导阻滞,1 例发生卒中。3 年随访时,15.0%的患者出现轻度或中度瓣周反流,无中度或重度瓣周漏。此外,89.5%的患者被归类为纽约心脏协会(NYHA)心功能 I 级或 II 级,心功能显著改善。

结论

J-Valve 系统在治疗 AR 方面取得了积极的治疗效果,在控制病情方面效果显著,并显著改善心力衰竭症状和心脏重构。然而,由于样本量有限且部分随访数据缺失,强调需要进行更全面的长期随访的进一步研究,以充分验证这些结果。

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